Senior Medical Writing Specialist

Job Title: Senior Medical Writing Specialist

Chipton Ross is seeking a Medical Writing Specialist for a remote contract opportunity.

Job Summary:

The healthcare industry requires compliance with regulations worldwide. Our client produces clinical documents supporting the safety and efficacy of their products. The Senior Medical Writing Specialist in the Worldwide Medical Advanced Surgery sector will write and edit clinical documents for regulatory submissions. Candidates should have a scientific background and be fluent in English (both written and spoken).

Responsibilities:

1. Develop high-quality clinical documents ensuring scientific excellence and regulatory compliance, including writing, interpreting, and summarizing clinical and non-clinical data.
2. Prepare documents such as investigator brochures, protocols, clinical study reports, integrated reports, technical documents, drug applications, manuscripts, and abstracts.
3. Ensure compliance with regulatory requirements and guidelines.
4. Collaborate with cross-functional teams and represent Medical Writing in meetings.
5. Prepare document timelines with guidance from management.
6. Conduct literature searches.
7. Deepen knowledge in specific therapeutic areas.

Qualifications:

1. Experience in scientific and medical writing.
2. Ability to evaluate scientific data and present it clearly and concisely.
3. Strong organizational skills and attention to detail.
4. Familiarity with clinical trial and regulatory submission templates.
5. Knowledge of global regulatory authority regulations and guidance.
6. Ability to manage multiple projects with competing priorities.
7. Experience working remotely in a team environment and independently.
8. Knowledge of medical statistics.
9. Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, OneNote, Outlook, Teams).

Education and Experience:

BSc or MSc in a scientific or clinical discipline. At least 5 years of experience in scientific or medical writing is preferred but not mandatory.

Additional Details:

• Work Hours: First Shift, Full Time.
• Employment contingent on passing a drug screen and background check.